Largo, Maryland
Raleigh, North Carolina
Baltimore, Maryland
Baltimore, Maryland
San Francisco, California
Modesto, California
Posted: 07-Mar-25
Location: Madison, Wisconsin
Type: Full-time
Categories:
Internal Number: 258004
Imagine being involved in cutting edge projects that change the course of our industry daily. Labcorp?s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. You will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.
We have an excellent career opportunity for a Study Director I-Pharmacokinetics to join our team in Madison, WI. If you have a passion for science and enjoy a fast paced, collaborative environment, this is an ideal position for you!
Position Summary:
The Study Director I is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements. They are the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance. They will demonstrate competence in directing standard study types. Most studies undertaken will be non-GLP studies and routine GLP studies.
Candidates given best consideration will possess the following:
Experience in a range of techniques and approaches relevant to the department and/or unique expertise for a specific scientific service
Awareness of requirements for working within a GLP, GCP and GMP (as appropriate) environment
Previous data interpretation and report writing experience
Strong client relationship building and management skills
Excellent communication skills
Strong attention to detail, organization and time management skills
Ability to help foster a high professional standard and encourage good staff relationships
Working knowledge of software (e.g., MS Word, Excel) and general IT skills
Essential Job Duties:
Ensures that studies are performed to the required scientific, regulatory and client standards, in accordance with the study protocol and Covance standard operating procedures.
Applies up to date knowledge and application of current GLP, GCP and regulatory guidelines relevant to study conduct.
Uses knowledge of relevant assays and general expertise in the drug development process to offer guidance and suggestions on study design to meet client?s requirements, and plans accordingly (timelines, critical deadlines, etc.).
Prepares and completes study documents in partnership with study coordinators to meet client and regulatory requirements (outlines, protocols, reports, etc.). Ensures final report is compliant with SOPs and regulatory guidelines.
Manages projects and client interactions. Provides clients with regular progress updates and ensures their expectations are met.
Effectively communicates study design, project requirements, and performance expectations to the study team. Maintains regular and timely communication within study team including start-up, ongoing, and close-out meetings. Ensures that all study communication is documented and maintained.
Monitors/reviews study progress always and anticipates problems that may affect timing, quality. Considers & discusses appropriate actions to resolve such problems. Issues directives and follows up to ensure compliance to requirements.
Manages study changes and ensures all additional costs are captured. Applies company procedures for financial, resource and contracting requirements.
Consistently meets on time delivery targets (protocols, results, reports).
Monitors and reviews client satisfaction to provide feedback to team and ensure repeat business.
Education:
Bachelor of Science degree in an appropriate scientific discipline with some research experience in a relevant field required
PhD preferred
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Why People choose to work at Labcorp:
At Labcorp, it is our people that make us great - it?s what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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